FDA DSCSA Pilot: A Q&A with TraceLink’s John Jacey

TraceLink’s John Jacey describes how the FDA’s pilot programme will help shape the Drug Supply Chain Security Act (DSCSA) system to identify and trace prescription drugs in the supply chain.

SI: A number of companies are getting involved – am I right in thinking this is a series of ‘pilots’ rather than a single venture?

Under the Drug Supply Chain Security Act (DSCSA) the Food and Drug Administration (FDA) is charged with working across the Life Sciences eco-system to comply with the law.

To that end, the FDA initiated the DSCSA Pilot Program to prompt the industry to collaborate and develop the key attributes of piloting end-to-end systems capable of meeting the final 2023 DSCSA deadline requiring full unit level traceability across the supply chain.

When the FDA called for pilot project participants, it was seeking representatives of the pharmaceutical distribution supply chain including contract manufacturers, manufacturers, wholesale distributors, repackagers, returns processors, logistics partners, technology solution providers, and dispensers.

TraceLink’s submission to the FDA pilot program included two workstreams: an interoperable blockchain network solution, and a solution to digitally manage drug recalls across a digital supply network.

Both workstreams bring together diverse stakeholders from across the entire supply chain and in collaboration with regulators, aims to provide insight to enhance patient safety, while addressing tough business and compliance challenges through network connectivity and innovative software solutions.

SI: Should this be viewed as a kind of competitive tender?

Actually, it’s closer to industry-group sessions that seek interoperability, consensus and stakeholder input to develop, shape, and inform the FDA and the industry as to how these initiatives might be achieved by 2023.

The program (of which the structure was decided after a series of public meetings) seeks to find industry consensus and solutions that will help stakeholders of all sizes prepare for 2023 as well as leverage current investments in serialization and Network connectivity.

SI: What is the format of TraceLink’s project?

TraceLink’s blockchain workstream will bring together all stakeholders from the supply chain to evaluate how blockchain can be used to help companies meet DSCSA transaction information gathering requirements.

The blockchain workstream will not necessarily focus on a technology solution, although we will leverage TraceLink’s blockchain solution, Trace Histories, as one of the tools the industry can use to develop a blueprint for an open, interoperable network to achieve full unit level traceability across the supply chain. We will be initially focusing on topics such as interoperability, data ownership and permissioning, governance, credentialing of Network participants and data with the goal of supporting suspect product investigations across a distributed supply network. We have a current hypothesis that a distributed ledger approach will enable safe and secure information exchange between authorized partners via a unique “gather upon request” model.

Unlike other industry initiatives calling to adopt a single common blockchain system for the industry, our working model is targeted to support interoperability across blockchain and non-blockchain networks. In the US, we’re not limited to only one set of standards, we’re collaborating to find commonly adopted, commonly used technologies and platforms. We then plan to share this understanding to create common solutions and best practice implementation blueprints.

The second workstream for digital recalls, tackles the highly fragmented and manual process of drug recalls. The FDA very clearly stated in its vision for 2023 that it didn’t want the focus just to be on compliance, it wanted to prompt the industry to look at all the tools, processes and technology being developed and explore other supply chain and patient benefits that may be achieved. One big area of focus is on product recalls – it’s a safety issue and a huge cost and efficiency drain on the pharmaceutical supply chain.

While each individual stakeholder in the supply chain may have good current, but manual, processes, the recalls process is fragmented and difficult to execute across the industry. There are duplicative efforts full of paper processes. Like Trace Histories, we will be exploring topics of governance, integration, interoperability, data ownership and visibility, but additionally, we will be considering what can be accomplished immediately by using a Network approach to recalls communications and leveraging lot level Transaction History data. As a whole, we will be looking at what the recall process will look like in a fully serialized market in 2023 and beyond, however, we don’t believe that we have to wait until 2023 to have an immediate positive impact on patient safety relative to the recalls process.

SI: Who are your partners in the programme? How do you intend to benchmark your proposal/measure outcomes?

TraceLink is very aligned with the FDA’s goal of having diverse participants involved in our pilot workstreams, not just across the supply chain, but within each stakeholder segment. Unique to TraceLink’s pilot project is the inclusion of a very diverse set of industry participants including contract manufacturers (both recalls and suspect product investigations could impact upstream partners), large pharmaceutical manufacturers, biopharmaceutical companies, repackagers, wholesale distributors, major retail pharmacy chains, diversified healthcare systems, third-party logistics providers, and returns processors. In terms of diversity within the sectors, we have some of the largest manufacturers, wholesalers, and retail chain drug participants, yet we also have small biotech and regional and specialty wholesale, dispensers, and hospital groups joining us to ensure that all voices are heard.

These companies, many of whom are our customers, represent the scope, complexities, and operational use cases from all segments of the supply chain. Combining insights from these leading companies with TraceLink’s digital supply network will garner compelling information that will contribute to the innovation, security, and interoperability of the supply chain and improve patient safety. In regard to reporting progress and outcomes, we have established a participation and reporting cadence with the FDA and their DSCSA Pilot program office.

SI: In your opinion, what form would an ‘ideal’ interoperable system take? What value do you think the findings will have for the pharma supply chain?

Essentially the “ideal” system is what the FDA’s pilot process is designed to uncover: common solutions that serve the interests of all stakeholders and allow participation regardless of size and technical capabilities.

Ultimately, the entire effort will accumulate a wealth of knowledge across all the different, diverse stakeholders and address a number of open issues that require settlement and agreement before the vision of DSCSA 2023 can be realized. The great thing about the program is that it will help all involved create a heterogenous technology solution and surface many operational and governance topics that have to be addressed before full-scale adoption can take place.

SI: Where do you see the challenges/weak links? Are there any points of divergence between technology providers and the FDA/federal authorities?

We don’t yet know if there are any weak links or point of divergence. What we do know is that there are many topics and areas that need to be discussed and explored throughout the process. 

For both workstreams, our cross-industry workgroup will be discussing best practices, operational challenges, interoperability and impact on business processes and current and emerging trade relations. 

SI: In general terms, how do you view the readiness of supply chain partners for the next deadline on verifying serialized saleable returns by Nov. 27, 2019, as well as the requirement for an interoperable, electronic system in 2023?

Solution providers, along with many in industry, have been working to define the standards by which verifications are done. A set of standards around Verification Router Services (VRS) that will enable compliance with the law have been ratified by GS1 and solution providers are completing the interoperability testing that will enable these systems to communicate with each other. 

As a result of the industry-wide effort, standards setting and interoperability testing that has been conducted, companies should not delay preparations for meeting the November 2019 saleable returns deadline.

Regarding 2023, we are solidly backing the effort by all stakeholders to be prepared to meet both the law, as well as the opportunity to collaborate with federal authorities to realize their vision of patient safety and a secure, reliable pharmaceutical supply chain.

SI: Where are the vulnerabilities/key challenges?

The volume of returned products is a challenge, which is a major reason why companies should not delay their preparations for the November 2019 deadline. A recent analysis by the Healthcare Distribution Alliance (HDA) revealed that 60 million units are returned annually. To help distributors and manufacturers minimize the impact of compliance and extend the value serialized data can provide their organizations, an HDA task force developed the VRS model, a near real-time solution to route verification request and responses.

A recent TraceLink webinar poll on the topic asked attendees: “What is your biggest concern about saleable returns verification?” According to about 10 per cent, impact on operational efficiency was a major concern. Anxiety from being overwhelmed by verification requests was concerning for 10 per cent and being cited by the FDA for non-compliance made the top of the list of concerns with 62 per cent of attendees noting anxiety about regulatory scrutiny. Finally, some 14 per cent indicated network performance and reliability was another top-of- mind concern.

John Jacey has been with TraceLink since 2010 and in the pharmaceutical serialization and track and trace industry since 2004. He is currently part of TraceLink’s Digitalization Strategy team, working across TraceLink’s teams and its customer base to explore and realize new value opportunities from existing investments in serialization and the TraceLink Network.